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Associate Medical Director, Drug Safety
4 months ago
Job Description
What you'll do:
The Associate Medical Director, Global Safety Physician will be responsible for global pharmacovigilance for investigational and/or marketed products, including review and analysis of safety data, design of clinical trials, identification and investigation of safety signals, management of benefit-risk profile for assigned compounds and products. The Global Safety Physician will represent Biogen Safety in internal and external meetings. The Global Safety Physician can be appointed as the Global Safety Officer for a specific product.
The Global Safety Physician will demonstrate the flexibility and capability to function at a high level across multiple disease areas and will be comfortable working in an entrepreneurial environment to advance the safety and biological understanding of compounds through their life cycle.
1. Manage safety surveillance for assigned products
2. Provide safety strategic leadership for clinical development programs
a. Integrate the safety scientific component to build a strategic framework for clinical development plans.
3. Develop and maintain relationships with counterparts in Clinical Development, Pre-Clinical Safety, Research, Regulatory, Clinical Operations, Clinical Pharmacology, Quantitative Sciences, Translational Sciences, Worldwide Medical.
4. Ensure the accurate and timely completion and reporting of periodic and expedited safety reports, in compliance with internal timelines and timelines set by regulatory authorities.
This position is hybrid based in Cambridge, MA (USA).
Who You Are
You are a proven leader in safety & pharmacovigilance. You strive on developing, executing and advancing successful programs in development. You have experience working / leading high performing teams; providing the necessary guidance and mentoring for all to reach their goals.
Qualifications
Required Skills
- Minimum 3+ years experience in the pharmaceutical industry or clinical care setting; ideally specific to pharmacovigilance.
- Prior experience in clinical trials preferred; academic and/or industry.
- Knowledge of pre- and post- marketing US and EU regulations
Preferred Skills
- MD or MD/PhD required; subspecialty focus in neuroscience, psychiatry, immunology, rare diseases
Additional information
The Associate Medical Director, Global Safety Physician will be responsible for global pharmacovigilance for investigational and/or marketed products, including review and analysis of safety data, design of clinical trials, identification and investigation of safety signals, management of benefit-risk profile for assigned compounds and products.
#LTD-1
Additional Information
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
